Category - SaMD (Software as a Medical Device)

Explore SaMD (Software as a Medical Device) at Yoctobe. Learn about regulatory compliance (IEC 62304, MDR) for medical device software in the UK’s digital health sector.

Articles

SaMD Classification and Conformity Assessment: A Comprehensive Analysis of UK and EU Regulatory Frameworks
Is my software a medical device?
Medical Device Regulations (EU and UK)
Medical Device Claims & Intended Purpose
SaMD Risk-Based Classification
Conformity Assessment Routes for Software as a Medical Device (SaMD)
Essential General Requirements for Software as a Medical Device (SaMD) Conformity Assessment
Conformity Assessment Route for Class I SaMD
Conformity Assessment Route for Class IIa SaMD
Conformity Assessment Route for Class IIb SaMD
Conformity Assessment Route for Class III SaMD
Clinical Evaluations & Clinical Investigations for SaMD Development
MHRA Registration and Approved Bodies for SaMD
SaMD Post-Market Surveillance
SaMD Digital Technology Assessment Criteria (DTAC)
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